The present invention relates generally to the field of electrical neuromuscular stimulation for treatment of incontinence. In particular, the present invention is a molded electrode device with handle having increased efficacy, safety, and comfort.
Incontinence affects an estimated 12-15 million adults nationwide. Defined as the inability to retain urine or feces through loss of sphincter control, incontinence costs society an estimated $10.3 billion annually.
Electrical neuromuscular stimulation is widely used to assist persons afflicted with motor or nerve dysfunctions in performing muscle contraction maneuvers. This technique is also used to re-educate patients in the proper use of the dysfunctional muscles. For the treatment of incontinence, pulses of electrical current stimulate sensory nerve fibers located within the vagina or rectum. This in turn causes reflex contractions of the pelvic floor muscles and reflex inhibition of a spastic bladder muscle.
"Stress incontinence" can result from the patient's inability to properly contract or close the external sphincter of the urethra when there is increased pressure on the bladder, such as during coughing or lifting. It has been shown that neuromuscular stimulation can cause contractions of the pelvic floor by means of a vaginal or anal electrode which effectively prevents the unwanted leakage of urine. Furthermore, through the use of such an electrode, patients can educate themselves to voluntarily or automatically impede the flow of urine. Another important application of the pelvic floor contractions is the exercise and toning of the muscles of the pelvic floor which support the bladder, urethra, and other organs. Pelvic floor muscles which have become lax or stretched due to either the process of child birth, obesity, multiple sclerosis, or degenerative changes associated with aging can be strengthened and tightened to properly support the particular organs, thus positively affecting the patient's ability to maintain continence.
Another common form of incontinence is called "urge incontinence". This condition results from a hyperactive or spastic bladder muscle. Electrical stimulation to sensory nerve fibers can activate certain reflex contractions of the pelvic floor muscles which inhibit the inappropriate bladder contractions associated with urge incontinence.
Anal incontinence is a similar problem. It is the inability to prevent the involuntary expulsion of gas, liquid, or solids from the lower bowel. The ani sphincter muscles of continent persons prevent involuntary expulsions from the lower bowel. The ani sphincter is made up of two distinct muscles; the external anal sphincter and the internal anal sphincter. The external sphincter, made up of striated muscles, is capable of voluntary control. Conversely, the internal sphincter, made up of smooth muscle, is incapable of voluntary control. Once again, neuromuscular stimulation via an anal electrode can cause contractions of pelvic floor muscles, including the dysfunctional external sphincter muscle to effectively prevent incontinence. Furthermore, patients can educate themselves to voluntarily or automatically prevent these involuntary expulsions.
Electrical neuromuscular stimulation has become a recognized and accepted form for the treatment of incontinence. Several prior art references disclose vaginal or anal electrodes for the prevention of incontinence. However, these prior art references have short-comings which limit their effectiveness. First, prior art electrodes have a tendency to be pulled inward into the rectum during stimulation periods due to muscle contractions of pelvic floor muscles. They also have a tendency to fall out of the vagina or rectum during non-stimulation periods. Second, the diameter and rigid composition of prior art electrodes often cause discomfort and pain to the patient.
Therefore, there is a continuing need for an improved flexible electrode for use in the vagina or rectum which can effectively restore continence, is securely held in place during either stimulation or non-stimulation periods, and will be comfortable to the patient.